MAUDE Adverse Event Report: B.BRAUN SURGICAL SA BONE WAX 24X2.5G; HAEMOSTYPTICS, PROPHYLAXIS OF

Model Number 1029754

Device Problems Incomplete or Missing Packaging (2312); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u.S.K000021.If additional information is received a follow up report will be submitted.

Event Description

The reporter indicated that there was no product inside the package.No other information has been provided.

Manufacturer Narrative

(b)(4) (importer) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number: e2014012.Investigation: samples received: one closed and empty unit.Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received one closed and empty sample.The primary and secondary packaging are intact.The primary pack was marked as empty during production but it was not discarded.We assume a human error of the operator that did not discard the defective unit.As there are no previous complaints, we assume that this is an isolated unit.The device history record has been reviewed and no deviations have been found.Remarks: we will inform the personnel involved about this incidence.Final conclusion: taking into account that the result of sample received does not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the sample received.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.You will receive a credit note for one box of product as compensation.No corrective/preventive actions needed.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: HAEMOSTYPTICS, PROPHYLAXIS OF
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8587346
• MDR Text Key: 144322592
• Report Number: 3003639970-2019-00391
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 218504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Distributor Facility Aware Date: 05/13/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1